FAQ -

API, Route of Administration, Drug Listing

What do I enter for Route of Administration when listing API?

For API, enter Route of Administration as NOT APPLICABLE

NDC Code, Setid, Drug Listing

If Company A has listed NDC 1111-11-11111, do I need to list it as well? [need example here]

No. Each NDC code must be associated with only 1 setid.

Drug Listing, Changes-Being-Effected, CBE

What happens if I list a change to labeling before I submit the CBE to the Review Division?

The change to labeling will be posted to Daily Med. The CBE will go to the Review Division for review.

Drug Listing, Changes-Being-Effected, CBE

What happens if I submit the CBE to the Review Division and do not list the change to labeling via ELIST?

The CBE will go to the Review Division for review. However, the change to labeling will NOT be posted to Daily Med.